BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP TUBING SET

    MDR report key: 1690996 · Received April 21, 2010

    Report

    Report Number
    1690996
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    April 10, 2010
    Report Date
    April 21, 2010
    Manufacturer
    WALKMED INFUSION LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    UPON DISCONNECTING WALKMED CONTINUOUS INFUSION TUBING FROM B BRAUN ULTRASITE VALVE LUER CONNECTOR, NOTED THAT WALKMED CONNECTOR BROKEN WITH END OF B BRAUN CONNECTOR LODGED IN THE VALVE. NO CHEMOTHERAPY LEAKAGE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP TUBING SET IV TUBING FPA WALKMED INFUSION LLC * *
    2 ULTRASITE IV TUBING CONNECTOR FPA B BRAUN * 60989688

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CHEMOTHERAPY